NCT03605771进行中（未招募）不适用
Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain
Grupo Español Multidisciplinar de Melanoma78 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年8月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 78
- 主要终点
- Sample Characteristics
研究概览
简要总结
This is an observational, multicentre epidemiological study with a longitudinal cohort in which information will be retrieved from medical records of patients with advanced metastatic or unresectable melanoma at first diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8,
- •First diagnosis is understood as: a. Disease onset as metastatic or unresectable disease; b. First metastatic or unresectable relapse in the pre-established dates (after January 8, 2018) in a patient with previous localised melanoma and completely resected on dates before the pre-inclusion period.
- •Signing the Informed Consent Form (ICF).
- •A patient may have received the first or subsequent treatments for metastatic or unresectable disease in a hospital other than the centre where the ICF was signed, as long as the patient meets the inclusion criteria
- •A patient can only sign one ICF (cannot sign an ICF in two different centres).
- •If a patient signs the ICF in a centre during the first-line therapy and then goes to another centre with consideration for the following lines: If the centre is associated with the GEM-1801 study, researchers will do their best to update the following lines and the patient status, introducing the new information in the centre where the ICF was initially signed. This information will be provided by the patient before contacting the principal investigator and always with prior consent of the patient, who will have previously provided the consent to contact by telephone for this purpose. If this second (or subsequent) centre is not associated with the GEM- 1801 study, this will be considered loss of follow-up, unless the patient returns to the GEM-1801 start centre, wherein the reporting physicians will do their best to update the information from other centres, always with prior patient consent, who will have previously signed the ICF; c) A patient card with the assigned code will be delivered.
排除标准
- •Any patient not complying with inclusion criteria.
研究组 & 干预措施
Advanced Melanoma
Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. First diagnosis is understood as:
- Disease onset as metastatic or unresectable disease.
- First metastatic or unresectable relapse in the pre-established dates (after January 8, 2018) in a patient with previous localised melanoma and completely resected on dates before the pre-inclusion period.
干预措施: Daily Clinical Practice (Other)
结局指标
主要结局
Sample Characteristics
时间窗: Baseline
Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.
次要结局
未报告次要终点
研究者
研究点 (78)
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